- are EGFR mutation-negative or unknown provided they had disease progression
after achieving either response or stable disease for at least 6 months from a
previous treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)

5. Severe alteration in serum fasting cholesterol (equal or more than 350 mg/dL) or
triglycerides (equal or more than 400 mg/dL). Patients may be allowed to enrol on
the trial after initiation of lipid lowering agents.

6. Requirement for treatment with any of the prohibited concomitant medications:

- Concomitant CYP3A4 inhibitors within the past 7 days before start of therapy or
concomitantly with this study.

- Concomitant CYP3A4 inducers within the past 14 days before start of therapy or
concomitantly with this study.

7. Any contraindications for therapy with Sirolimus.

8. Known hypersensitivity to BIBW 2992, Sirolimus or other rapamycin analogues
(everolimus, temsirolimus, deforolimus, etc.) or the excipients of any of the trial
drugs.

9. Use of any investigational drug within 4 weeks before start of therapy.

Start Date:

Completion Date:

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